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Evaluating the Relationship Between Metabolic Syndrome and Liver Biopsy-Proven Non-Alcoholic Steatohepatitis in China: A Multicenter Cross-Sectional Study Design

Abstract

Introduction

Non-alcoholic steatohepatitis (NASH) is a serious form of non-alcoholic fatty liver disease (NAFLD) that can progress to advanced fibrosis, cirrhosis, and hepatocellular carcinoma. Differentiating between non-alcoholic fatty liver (NAFL) and NASH/advanced fibrosis is an important step in the management of NAFLD. Metabolic syndrome (MS) and its components are important risk factors for NAFLD, and NASH is thought to be the hepatic injury of MS. The prevalence of NASH among NAFLD patients with MS is thought to be high. In China, NAFLD is a relatively new public health concern, and the current prevalence of NASH among Chinese liver biopsy-proven NAFLD patients with and without MS is not known.

Methods

This multicenter, cross-sectional study will investigate the prevalence of NASH in approximately 480 Chinese NAFLD patients. Patients will be eligible for enrollment if they have biopsy-proven NAFLD and if their liver biopsies are available for rereading. For our analysis, patients will be stratified according to the presence/absence of MS, and the prevalence of NASH in the subgroups will be compared. Other possible tests that could indicate a risk of NASH, including transient elastography, ultrasonography, cytokeratin-18, liver function tests, and others, will be studied in an effort to derive a practical, noninvasive predictive model for NASH.

Discussion

Patients with NAFL who have MS may also have a very high risk of developing NASH. The present study will inform about the risk of NASH in Chinese liver biopsy-proven NAFLD patients with and without MS.

Trial Registration

This study registered at http://www.chictr.org.cn (registration number: ChiCTR-OOC-16007902).

Funding

Sanofi (China) Investment Co., Ltd.

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Acknowledgments

Sponsorship and article processing charges for this study were funded by Sanofi (China) Investment Co., Ltd. We thank Lichuang Men from the Sanofi statistical team for his contributions to our study design. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. Editorial support in the preparation of this publication was provided by Manette Williams (PhD) from Nucleus Shanghai and paid for by Sanofi. The authors, individually and collectively, are responsible for all content and editorial decisions and received no payment from Sanofi directly or indirectly (through a third party) related to the development of this publication.

Disclosures

Xu Zhengjie, Shi Junping, Jia Jidong, and Fan Jian-Gao declare that they have nothing to disclose. Yu Derong is an employee of Sanofi (China) Investment Co., Ltd Shanghai Branch. Zhu Lijuan is an employee of Sanofi (China) Investment Co., Ltd Shanghai Branch.

Compliance with Ethics Guidelines

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013. Informed consent will be waived in view of the retrospective nature of this study and that no sensitive patient data are involved. Amendments to the protocol will take effect only upon approval by the institutional review boards.

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Correspondence to Ji-Dong Jia or Jian-Gao Fan.

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Z.-J. Xu and J.-P. Shi are joint first authors.

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Xu, ZJ., Shi, JP., Yu, DR. et al. Evaluating the Relationship Between Metabolic Syndrome and Liver Biopsy-Proven Non-Alcoholic Steatohepatitis in China: A Multicenter Cross-Sectional Study Design. Adv Ther 33, 2069–2081 (2016). https://doi.org/10.1007/s12325-016-0416-4

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  • DOI: https://doi.org/10.1007/s12325-016-0416-4

Keywords

  • Diagnosis
  • Gastroenterology
  • Liver biopsy
  • Metabolic syndrome
  • Non-alcoholic fatty liver disease
  • Non-alcoholic steatohepatitis